An Analysis Of PHARMACEUTICAL WATER SYSTEMS Strategies... Here's What We Learned

Performing a water system excursion investigation and not being able to definitively conclude the root cause is one of the most frustrating experiences for a pharmaceutical company. Understandable although the situation is, it is important to bear in mind that this is avoidable. Most errors in a water system excursion investigation that ends up failing to help zero in on the exact root cause are manmade, and can be completely prevented, if the right steps are taken.

Most pharmaceutical organizations face this situation because they fail to see that all that they are required to incorporate are a few rational changes to their action "trigger values", sampling and testing, all of which can be done even as they are still able to see real system problems with clarity when they do occur.

The result of doing an effective and accurate waters systems excursion investigation is vastly reduced cuts in resources costs, production downtime, product losses, and a host of other costs that can be invested prudently and productively.

Organizations that are serious about all these now have a wonderful opportunity to set their water system excursion investigation right and derive the correct values. A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how.

For this ninety-minute session, which is being organized on June 27, Compliance4All brings none lesser than the globally acclaimed honcho of pharmaceutical water systems, Teri C. Soli, President of Soli Pharma Solutions, Inc., as Speaker To enroll for this invaluable learning session, please log on to

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At this session, Dr. Soli will help participants understand how poorly designated trigger values, poorly designed use points, or poorly executed sampling or testing can lead to erroneous results with water system controls. He will help participants explore these possible causes and will provide effective alternatives that will help them to avoid most of their current redundant excursions. They will also be able to understand how to build supporting data useful in pinpointing causes in situations where investigations are absolutely unavoidable.

Dr. Soli will cover the following areas at this webinar:

• What are excursions?
• Water system dilemma: process control or quality control (utility or raw material), or both
• Intended functions of Alert/Action Levels and Specifications
• Investigation, necessary and often fruitless
• Excursion responses and impact
• Criticality of valves, hoses, & outlet flushing
• Diagnosing the source of the problem
• Minimizing unnecessary excursion responses through best practices
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About the expert: Dr. Teri C. Soli’s firm offers troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control.

Dr. Soli is a recognized global expert in contamination and biofilm control in the biopharmaceutical, medical device, and personal care product industries. He has authored numerous articles in Pharmacopeial Forum, Pharmaceutical Engineering, and Pharmaceutical Technology, as well as other publications and has authored chapters in many books and industry guides published by PDA and ISPE.

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

A broad variety of organizations that work in various industries and activities that require regulatory compliance trainings benefits in major ways from Compliance4All’s professional trainings. These trainings are relevant, focused and cost effective, and are on matters that relate to the day-to-day work that regulatory professionals carry out.

About the Author

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.

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